Do Safety Warnings Change Prescribing among the US Dialysis Population?

安全警告会改变美国透析人群的处方吗？

• 批准号: 8267550
• 负责人: Mae Thamer
• 金额: $ 5.06万
• 依托单位: MEDICAL TECHNOLOGY AND PRACTICE PATTERNS
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-06-01 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8267550
• 关键词: Do; Safety; Warnings; Change; Prescribing

Do Safety Warnings Change Prescribing among the US Dialysis Population? ABSTRACT Objectives On March 9, 2007, FDA issued a public health advisory and Black Box warning outlining new safety information, including revised product labeling about erythropoiesis- stimulating agents (ESAs), widely-used drugs for the treatment of anemia associated with renal disease. The goal of this proposal is to determine if these new recommendations resulted in a change in physician prescribing among all US dialysis patients covered by the Medicare End-Stage Disease (ESRD) program. Methods Computerized United States Renal Disease System (USRDS) data from March 2006 through March 2009 are proposed to evaluate prescribing patterns in the year before and two years after the FDA Public Health Advisory. An interrupted time series model, based on all outpatient dialysis encounters indicating use of ESAs will be used to assess the impact of the FDA Black Box Warnings in influencing physician prescribing. Results We will show trends in prescribing of ESAs for anemia associated with renal failure (commonly found among nearly all dialysis patients) before and after the FDA warnings. We will assess whether changes in prescribing can be attributed to the FDA Public Health Advisory. Results will be stratified by patient demographics (age, race, gender), responsiveness to therapy (achieved hemoglobin >10 g/dL), cause of ESRD (diabetes, hypertension, etc.), vintage (length of time on dialysis), and facility characteristics (chain status, size of facility and profit status). Conclusions/Implications We will show whether two years after a highly publicized FDS Public Health Advisory (a Black Box Warning that went out to all practicing nephrologists) indicating the safety risks associated with ESA therapy and recommendations to use 'the lowest dose possible to avoid blood transfusions' resulted in a decline in the previously high ESA doses observed among dialysis patients. Using 'real world' prescription data among a census of Medicare ESRD patients on dialysis, we will investigate whether the FDA recommendations from the March 2007 advisory meeting were coincident with a change in physician prescribing patterns. We will show whether - without accompanying changes in the reimbursement structure, i.e., higher ESA doses continued to be profitable during our study period - physicians changed their ESA prescribing habits as a result of the FDA warnings. This study presents a unique opportunity to examine the dissemination of grave Black Box warnings and the willingness of physicians to modify prescribing habits in treating a vulnerable population of dialysis patients.

安全警告会改变美国透析人群的处方吗？ 抽象的 目标 2007 年 3 月 9 日，FDA 发布了公共卫生咨询和黑匣子警告概述 新的安全信息，包括修订有关红细胞生成的产品标签- 刺激剂（ESA），广泛用于治疗与贫血相关的药物 肾脏疾病。该提案的目标是确定这些新建议是否 导致医生对所有美国透析患者的处方发生了变化 医疗保险终末期疾病 (ESRD) 计划。 方法 2006 年 3 月的计算机化美国肾脏病系统 (USRDS) 数据 提议截至 2009 年 3 月评估前一年和后一年的处方模式 FDA 公共卫生咨询发布两年后。间断时间序列模型， 基于所有门诊透析患者的情况，表明 ESA 的使用将用于评估 FDA 黑盒警告对医生处方的影响。 结果 我们将展示 ESA 治疗肾衰竭相关贫血的趋势 （在几乎所有透析患者中​​常见）在 FDA 警告之前和之后。 我们将评估处方的变化是否可归因于 FDA 公共卫生部门 咨询。结果将按患者人口统计数据（年龄、种族、性别）进行分层， 对治疗的反应（达到血红蛋白 >10 g/dL）、ESRD 的原因（糖尿病、 高血压等）、年份（透析时间长短）和设施特征（连锁店） 状况、设施规模和利润状况）。 结论/启示 我们将展示在广为人知的 FDS 公共卫生咨询（a 向所有执业肾科医生发出的黑​​框警告）表明安全 与 ESA 治疗相关的风险以及使用“尽可能最低剂量”的建议 避免输血导致先前高 ESA 剂量下降 在透析患者中​​观察到。使用人口普查中的“真实世界”处方数据 医疗保险 ESRD 患者接受透析，我们将调查 FDA 是否 2007 年 3 月咨询会议的建议与一项变更同时发生 在医生的处方模式中。我们将展示是否 - 没有陪同 报销结构的变化，即更高剂量的欧空局剂量继续有利可图 在我们的研究期间 - 医生改变了他们的 ESA 处方习惯，因为 FDA 警告。这项研究提供了一个独特的机会来检验 严重黑匣子警告的传播以及医生修改的意愿 制定治疗弱势透析患者群体的习惯。